3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

NCT05286593 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY00001584
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators seek to test bolus infusions (50ml/min) vs. slow infusions (20 ml/min) of Rb-82 on metrics of coronary blood flow assessed on a modern 3D PET/CT.

Conditions

Normal Healthy Volunteers Without Chronic Medical Conditions; Coronary Artery Disease; Cardiac Risk Factors; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82

  resting and stress myocardial blood flow in cc/min/g

  1 day

Secondary Outcomes (1)

• Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82

  1 Day

Study Arms (3)

Normal volunteers

OTHER

Normal participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.

Drug: Slow Infusion of Rubidium-82

Clinical patients

OTHER

Clinical patients participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.

Drug: Slow Infusion of Rubidium-82

Infarcts

OTHER

Infarct participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.

Drug: Slow Infusion of Rubidium-82

Interventions

Slow Infusion of Rubidium-82 DRUG

Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion

Also known as: 20 mls/min of Rubidium-82

Normal volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal Volunteers
• Adults ≥18 and \<40 years old able to give informed consent.
• Ability to abstain from caffeine for 48 hours
• The "clinical" population
• Adults ≥18 years old able to give informed consent.
• Any cardiac risk factor including hypertension, hyperlipidemia, diabetes mellitus or tobacco use OR
• CAD defined by with history of PCI or CABG, Coronary Ca score\>400, or dense coronary calcifications noted on chest CT
• Ability to abstain from caffeine for 48 hours
• The "infarct" population
• Adults ≥18 years old able to give informed consent.
• Prior cardiac PET scan demonstrating a fixed defect ≥ 15% of the LV myocardium with relative uptake ≤60% maximum uptake.
• In addition, to the perfusion defect, each volunteer requires either:
• FDG PET or MRI viability studies confirming infarct OR
• akinesis and wall thinning on ECHO within the same territory as the PET defect in addition to Q-waves on ECG
• Ability to abstain from caffeine for 48 hours

You may not qualify if:

• Normal Volunteers
• Any chronic cardiac disease or condition (e.g., hypertension, hyperlipidemia)
• Any chronic systemic disease or condition (e.g., diabetes, systemic lupus, rheumatoid arthritis)
• Tobacco use
• Family history in a first degree relative with clinical CAD (h/o PCI, MI or CABG) in men \<55 or women \<65
• Severe claustrophobia
• Positive urine pregnancy test
• Inability to give informed consent
• BMI ≥ 30 or BMI\>25 and \<30 provided waist to hip ratio \>0.80 in women or 0.90 in men.
• The "clinical" and "infarct" populations
• Severe claustrophobia
• Hemodynamic instability or unstable symptoms
• Positive urine pregnancy test
• Inability to give informed consent

Sponsors & Collaborators

• Ochsner Health System: lead
• Bracco Corporate: collaborator

Study Sites (1)

Ochsner

New Orleans, Louisiana, 70120, United States

Location

Related Publications (14)

• Araujo LI, Lammertsma AA, Rhodes CG, McFalls EO, Iida H, Rechavia E, Galassi A, De Silva R, Jones T, Maseri A. Noninvasive quantification of regional myocardial blood flow in coronary artery disease with oxygen-15-labeled carbon dioxide inhalation and positron emission tomography. Circulation. 1991 Mar;83(3):875-85. doi: 10.1161/01.cir.83.3.875.

  PMID: 1900224 BACKGROUND

• Bergmann SR, Fox KA, Rand AL, McElvany KD, Welch MJ, Markham J, Sobel BE. Quantification of regional myocardial blood flow in vivo with H215O. Circulation. 1984 Oct;70(4):724-33. doi: 10.1161/01.cir.70.4.724.

  PMID: 6332687 BACKGROUND

• Sdringola S, Johnson NP, Kirkeeide RL, Cid E, Gould KL. Impact of unexpected factors on quantitative myocardial perfusion and coronary flow reserve in young, asymptomatic volunteers. JACC Cardiovasc Imaging. 2011 Apr;4(4):402-12. doi: 10.1016/j.jcmg.2011.02.008.

  PMID: 21492816 BACKGROUND

• Renaud JM, DaSilva JN, Beanlands RS, DeKemp RA. Characterizing the normal range of myocardial blood flow with (8)(2)rubidium and (1)(3)N-ammonia PET imaging. J Nucl Cardiol. 2013 Aug;20(4):578-91. doi: 10.1007/s12350-013-9721-3. Epub 2013 May 9.

  PMID: 23657833 BACKGROUND

• Merlet P, Mazoyer B, Hittinger L, Valette H, Saal JP, Bendriem B, Crozatier B, Castaigne A, Syrota A, Rande JL. Assessment of coronary reserve in man: comparison between positron emission tomography with oxygen-15-labeled water and intracoronary Doppler technique. J Nucl Med. 1993 Nov;34(11):1899-904.

  PMID: 8229231 BACKGROUND

• Kern MJ, Bach RG, Mechem CJ, Caracciolo EA, Aguirre FV, Miller LW, Donohue TJ. Variations in normal coronary vasodilatory reserve stratified by artery, gender, heart transplantation and coronary artery disease. J Am Coll Cardiol. 1996 Nov 1;28(5):1154-60. doi: 10.1016/S0735-1097(96)00327-0.

  PMID: 8890809 BACKGROUND

• Gewirtz H, Fischman AJ, Abraham S, Gilson M, Strauss HW, Alpert NM. Positron emission tomographic measurements of absolute regional myocardial blood flow permits identification of nonviable myocardium in patients with chronic myocardial infarction. J Am Coll Cardiol. 1994 Mar 15;23(4):851-9. doi: 10.1016/0735-1097(94)90629-7.

  PMID: 8106689 BACKGROUND

• Rivas F, Cobb FR, Bache RJ, Greenfield JC Jr. Relationship between blood flow to ischemic regions and extent of myocardial infarction. Serial measurement of blood flow to ischemic regions in dogs. Circ Res. 1976 May;38(5):439-47. doi: 10.1161/01.res.38.5.439.

  PMID: 1269083 BACKGROUND

• Kitkungvan D, Johnson NP, Roby AE, Patel MB, Kirkeeide R, Gould KL. Routine Clinical Quantitative Rest Stress Myocardial Perfusion for Managing Coronary Artery Disease: Clinical Relevance of Test-Retest Variability. JACC Cardiovasc Imaging. 2017 May;10(5):565-577. doi: 10.1016/j.jcmg.2016.09.019. Epub 2016 Dec 21.

  PMID: 28017383 BACKGROUND

• Murthy VL, Bateman TM, Beanlands RS, Berman DS, Borges-Neto S, Chareonthaitawee P, Cerqueira MD, deKemp RA, DePuey EG, Dilsizian V, Dorbala S, Ficaro EP, Garcia EV, Gewirtz H, Heller GV, Lewin HC, Malhotra S, Mann A, Ruddy TD, Schindler TH, Schwartz RG, Slomka PJ, Soman P, Di Carli MF, Einstein A, Russell R, Corbett JR. Clinical Quantification of Myocardial Blood Flow Using PET: Joint Position Paper of the SNMMI Cardiovascular Council and the ASNC. J Nucl Cardiol. 2018 Feb;25(1):269-297. doi: 10.1007/s12350-017-1110-x. No abstract available.

  PMID: 29243073 BACKGROUND

• Renaud JM, Yip K, Guimond J, Trottier M, Pibarot P, Turcotte E, Maguire C, Lalonde L, Gulenchyn K, Farncombe T, Wisenberg G, Moody J, Lee B, Port SC, Turkington TG, Beanlands RS, deKemp RA. Characterization of 3-Dimensional PET Systems for Accurate Quantification of Myocardial Blood Flow. J Nucl Med. 2017 Jan;58(1):103-109. doi: 10.2967/jnumed.116.174565. Epub 2016 Aug 18.

  PMID: 27539843 BACKGROUND

• Bui L, Kitkungvan D, Roby AE, Nguyen TT, Gould KL. Pitfalls in quantitative myocardial PET perfusion II: Arterial input function. J Nucl Cardiol. 2020 Apr;27(2):397-409. doi: 10.1007/s12350-020-02074-8. Epub 2020 Mar 3.

  PMID: 32128675 BACKGROUND

• Gould KL, Bui L, Kitkungvan D, Patel MB. Reliability and Reproducibility of Absolute Myocardial Blood Flow: Does It Depend on the PET/CT Technology, the Vasodilator, and/or the Software? Curr Cardiol Rep. 2021 Jan 22;23(3):12. doi: 10.1007/s11886-021-01449-8.

  PMID: 33483794 BACKGROUND

• Bober RM, Milani RV, Kachur SM, Morin DP. Assessment of resting myocardial blood flow in regions of known transmural scar to confirm accuracy and precision of 3D cardiac positron emission tomography. EJNMMI Res. 2023 Sep 27;13(1):87. doi: 10.1186/s13550-023-01037-7.

  PMID: 37752344 DERIVED

Related Links

• Quantification of Resting Myocardial Blood Flow Using Rubidum82 Positron Emission Tomography in Regions with MRI-Confirmed Myocardial Scar. Annals of Nuclear Cardiology.

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Cardiology

Model Details: All participants will receive a standard "high flow rate" weight based bolus of Rb-82 and a "low flow rate" weight based infusion of Rb-82. The bolus and infusion doses will be administered randomly at rest and stress however the bolus is considered the gold standard. In addition, under resting conditions, participants will also receive a third dose of Rb-82 that is either a bolus or low flow rate (assigned randomly).

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: March 18, 2022
• Study Start: December 28, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

US (1)